THE CLINICAL LABORATORY IN PHARMACEUTICAL DEVELOPMENT

被引：0
|
作者：
GUNTER, KC [1 ]
ROCK, RC [1 ]
机构：
[1] AMER SOC CLIN PATHOLOGISTS,CHICAGO,IL
来源：
THERAPEUTIC DRUG MONITORING | 1995年 / 17卷 / 02期
关键词：
CLINICAL TRIALS; LABORATORY MONITORING; PHARMACOLOGY;
D O I：
10.1097/00007691-199504000-00015
中图分类号：
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号：
1001 ;
摘要：
The clinical laboratory plays an important part in the development of new pharmaceutical agents. The nature of this role win vary depending on the stage of clinical development of the drug and the goals of a particular investigation. Therefore, it may be appropriate to conduct and interpret clinical trial laboratory tests differently from the standard methods used in routine clinical analysis. The training and background of laboratory directors are important in providing both prospective and on-site management of laboratory testing during pharmaceutical clinical trials.
引用
收藏
页码：189 / 194
页数：6
相关论文
共 50 条
  • [1] Pharmaceutical clinical development
    ODea, L
    Murray, M
    [J]. IDEA TO PRODUCT: THE PROCESS, 1996, : 103 - 114
  • [2] Requirements & role of the clinical laboratory in pharmaceutical clinical trials
    Cole, TG
    [J]. CLINICAL CHEMISTRY, 1999, 45 (06) : S40 - S40
  • [3] ORGANIZATION OF RESEARCH AND DEVELOPMENT LABORATORY IN PHARMACEUTICAL INDUSTRY
    FISHBURN, AG
    [J]. PRODUCTS ET PROBLEMS PHARMACEUTIQUES, 1970, 25 (01): : 59 - &
  • [4] ORGANIZATION OF A RESEARCH AND DEVELOPMENT LABORATORY IN A PHARMACEUTICAL COMPANY
    FISHBURN, AG
    [J]. ANNALES PHARMACEUTIQUES FRANCAISES, 1969, 27 (12): : 762 - &
  • [5] PRACTICAL ASPECTS OF LABORATORY AUTOMATION IN PHARMACEUTICAL DEVELOPMENT
    MCGONIGLE, EJ
    [J]. JOURNAL OF AUTOMATIC CHEMISTRY, 1993, 15 (01): : 3 - 8
  • [6] IMAGE STORAGE AND RETRIEVAL IN A PHARMACEUTICAL DEVELOPMENT LABORATORY
    OBOYLE, J
    [J]. DOCUMENT & IMAGE AUTOMATION, 1992, 12 (03): : 24 - 29
  • [7] Careers in pharmaceutical clinical development
    Freeman, J
    [J]. TRENDS IN PHARMACOLOGICAL SCIENCES, 1996, 17 (02) : 63 - 63
  • [8] Animal clinical laboratory medicine: Profiling practices for laboratory animals in pharmaceutical research
    Parzych, B. M.
    Kimball, J. P.
    [J]. CLINICAL CHEMISTRY, 2008, 54 (06) : A73 - A73
  • [9] Pharmaceutical process development applying automated laboratory reactors
    Chovan, Tibor
    Markovits, Imre
    Farkas, Bela
    Nagy, Kalman
    Nagy, Lajos
    Nyiri, Karoly
    Szeifert, Ferenc
    [J]. 16TH EUROPEAN SYMPOSIUM ON COMPUTER AIDED PROCESS ENGINEERING AND 9TH INTERNATIONAL SYMPOSIUM ON PROCESS SYSTEMS ENGINEERING, 2006, 21 : 1089 - 1094
  • [10] Grass pollen allergy vaccine BM32: a pharmaceutical development from laboratory to early clinical trials
    Stolz, F.
    Ettl, K.
    Focke, M.
    Hauer, M.
    Huber, H.
    Maderegger, B.
    Stegfellner, G.
    Valenta, R.
    Neubauer, A.
    [J]. ALLERGY, 2012, 67 : 600 - 600
12345